EMEA-000876-PIP07-15 - paediatric investigation plan

Eculizumab

Key facts

• Invented name:
  • Soliris
  • Soliris
• Active substance:
  Eculizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0229/2016
• PIP number:
  EMEA-000876-PIP07-15
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of delayed graft function after solid organ transplantation
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/09/2016
• Compliance check done:
  Nē

Decision

P/0229/2016: EMA decision of 1 September 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eculizumab (Soliris), (EMEA-000876-PIP07-15)

Adopted Reference Number: EMA/514471/2016